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5/9/2002

3M Recalls Pirbuterol Inhalers

Kate Traynor

3M Pharmaceuticals has issued an urgent recall affecting 16 lots of the company's 300-puff press-and-breathe Maxair pirbuterol acetate inhaler.

According to recall notices sent to pharmacies and distributors of 3M products, a "remote possibility" exists that the devices could malfunction and fail to deliver the medication.

The recall is restricted to the press-and-breathe pirbuterol acetate inhaler (NDC number 0089-0790-21) and does not apply to 3M's Maxair Autohaler, a breath-actuated device (NDC number 0089-0815-21). Lots under recall have expiration dates of August 2003 through December 2004.

The recall notice instructs pharmacies and wholesalers that have the recalled inhalers on hand to remove them from stock areas. Health maintenance organization pharmacies should contact 3M for a return authorization number and ship the recalled inhalers to the company's designated return-goods processor. Community pharmacies are asked to return the recalled units to the wholesaler, which will issue a credit for the devices.

Patients who bring a recalled press-and-breathe unit to their pharmacy along with a prescription for a 400-puff pirbuterol acetate autohaler can receive the autohaler at no charge. 3M has set up an exchange program through which pharmacies can return patients' recalled devices to the company and receive new autohalers to replace those given to patients.

Replacement press-and-breathe pirbuterol acetate inhalers are not currently available, according to the recall notice.

3M has set up a toll-free telephone number (800-390-1132) for patients and health care providers who have questions about the recall.